Uterus Transplantation Procedure From a Live Donor

Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy

Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to congenital problems, such as the Muller anomalies (Mayer Rockitansky Syndrome) or acquired by previous hysterectomy or intrauterine adhesions (Asherman's Syndrome). The uterine transplant would represent the only possibility for patients with an absolute uterine factor to achieve both genetic and gestational maternity.

Study Overview

• Status: Recruiting
• Conditions: Sterility, Female; Rokitansky Kuster Hauser Syndrome
• Intervention / Treatment: Procedure: Uterus transplantation

Detailed Description

To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the grafting technique already described by laparotomy. The objective of the present study is to develop a pilot program in the transplant of a living donor. We include 5 pairs of uterine donor-transplant recipients indicated for sterility by absolute uterine factor due to Mayer Rokitansky Syndrome. Patients will undergo surgery for this transplant and after 6 months of it with correct function of the graft, embryos will be transferred in order to achieve pregnancy. C-section will be performed for delivery. The attempt of two gestations (if there are sufficient cryopreserved embryos for a second gestation) and withdrawing the graft (hysterectomy) and, therefore, immunosuppression is agreed.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariona Rius, MD; Phone Number: 5436 932275400; Email: marius@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic
    • Principal Investigator: Francisco Carmona, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria Recipient:

• Patient with sterility for absolute uterine factor (malformation or previous surgery for benign processes).
• Age <40 years.
• Absence of pathology that contraindicates a complex surgical process, immunosuppression or gestation.
• Positive results to the IVF cycle prior to the surgery, obtaining quality embryos.
• Acceptance to participate in the study signing the informed consent.

Exclusion Criteria Recipient:

• Medical or surgical pathology that contraindicates a complex pelvic surgical procedure.
• Medical conditions that contraindicate, may aggravate or complicate the immunosuppressor treatment, such as neoplastic or preneoplasic diseases, chronic infectious diseases, autoimmune diseases, renal or liver failure.
• Medical or surgical pathology that contraindicates pregnancy.
• Anatomic alterations or vascular pathology that might difficult the vascular anastomosis: severe endometriosis, pelvic kidney, severe adherence syndrome or others.
• Uncontrolled psychopathology.

Inclusion Criteria donor:

• Age <65 years.
• First- or second-degree relatives.
• Completed reproductive desire.
• History of previous pregnancies and births.
• Absence of associated pathology that contraindicates prolonged and complex laparoscopic surgery (pneumopathies, heart disease, morbid obesity, …).
• Acceptance to participate in the study signing the informed consent

Exclusion Criteria donor:

• Potential future pregnancy desire.
• Surgery for the treatment of gender identity disorder.
• Infections: HIV or risk group, HBV-DNA and / or HBsAg positive, positive HCV, active bacterial sepsis, infections with multi-resistant bacteria, active tuberculosis or incomplete treatment of the same, Chagas disease, untreated active viral infections.
• Active malignant cancer of any location, except skin basal cell carcinoma. Treated cancer without current evidence of illness but with a follow-up of less than 5 years.
• Benign pelvic pathology: uterine fibroids, uterine malformations, severe endometriosis, severe adherence syndrome.
• Vascular pathology: malformations, atheromatosis, hypertensive or diabetic vasculopathy, connective tissue disease with vascular involvement.
• Premalignant pelvic pathology: pre-invasive cervical and/or vaginal, endometrial hyperplasia.
• BRCA mutation carriers or genes related to Lynch syndrome.
• History of implantation failure or multiple abortions of unknown cause.
• Contraindications for the surgical procedure of donation through laparoscopy: diabetes mellitus, liver disease, nephropathy, heart disease, pneumopathy, morbid obesity or high-risk cardiovascular factors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Recipient; Patient with absolut uterine factor will undergo uterus transplantation.

Procedure: Uterus transplantation; Patient will undergo surgery in order to transplant the graft (uterus). After that, a follow-up in order to detect early rejection. After 6 months, embryo transfer will be perfomed. Labour route will be C-Section. Two pregnancies are agreed, and after the second one, a hysterectomy will be performed in order to remove the graft.; Other Names: Ovarian estimulation; Immunosupression treatment; Embryo transfer; C-section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of grafts obtained by laparoscopy	It is feasible to obtain the graft by laparoscopy	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of healthy newborns	A healthy newborn after C-section	5 years

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Francisco Carmona, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Diaz-Feijoo B, Rius M, Gracia M, Musquera M, Magaldi M, Peri L, Alcaraz A, Carmona F. Donor robotic-assisted laparoscopy for uterus transplantation. Fertil Steril. 2022 Mar;117(3):651-652. doi: 10.1016/j.fertnstert.2021.11.026. Epub 2022 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 7, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: minimally invasive surgery; living donor; uterus transplantation; absolut uterine factor
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: TUX2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We will not share individual participant data, but we will publish all the results and protocols so other researchers have access to this information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No